This program will introduce the Quality System Regulation which defines the responsibilities for those who design, manufacture and distribute medical devices.

Description

This webinar is especially helpful for new startup companies that are entering the medical device field for the first time.

Why Should You Attend:

In the United States, the US Food and Drug Administrates Medical Devices through several different regulations, the principle one is the Quality System Regulation 21 CFR 820 (QSR). Other regulations include Registration and Listing, Labeling, Medical Device Reporting, and Corrections and Removals (Recalls). This program will introduce the Quality System Regulation which defines the responsibilities for those who design, manufacture and distribute medical devices.

Areas Covered in the seminar:

This session will identify who is responsible under the Quality System Regulation.

Identify the responsibilities of Suppliers to Medical Device Manufacturers.

Limits of the Design Control Regulation.

What is Validation? Includes Process, Design and Software Validation.

Preparing for Inspection.

Who will benefit:

This webinar is especially helpful for new startup companies that are entering the medical device field for the first time. It is also helpful for individuals that have not worked in the medical device field previously.

Personnel new to the field should take both Part 1 and Part 2 sessions.

Edwin L. Bills, was a Quality and Regulatory Affairs Director at an international medical device manufacturer for 5 years after serving in a variety of positions with increasing responsibility in the medical device industry, including Supplier Quality Engineer and Manager, Quality Systems and Regulatory Affairs Manager, Product Risk Manager, and Director of North American Service Quality. He is Regulatory Affairs Certified by RAPS, and also a Certified Quality Engineer, Certified Quality Auditor, and Certified Manager of Quality/ Organizational Excellence by ASQ and is an ASQ Senior Member.

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

Product Reviews

This product hasn't received any reviews yet. Be the first to review this product! Write review